Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to meet antimicrobial specifications, which poses a risk of infection, but the source text does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm (Item Code: 8888123408) manufactured by Covidien LLC. The recall is due to the possibility that the catheters may not meet antimicrobial specifications.
The affected units are identified by an expiry date of February 2018 and earlier. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally to numerous countries including Argentina, Austria, Belgium, Brazil, Canada, and others.
Healthcare providers and consumers should stop using the affected catheters and contact the manufacturer or their supplier for further instructions. This recall is classified as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item codes identified with an expiry date of February 2018 and earlier
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 62 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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